CERTIFICATION HANDBOOK Introduction Thank you for your interest in the Society for Clinical Data Management s (SCDM) Certified Clinical Data Manager (CCDM ) examination and for choosing SCDM as your certifying organization. About SCDM The Society for Clinical Data Management (SCDM) is a nonprofit professional society founded to advance the discipline of Clinical Data Management. The binding interest of all members is quality clinical data management practices. SCDM was founded in 1994 and has grown to be a premier data management organization which embodies upwards of 2,600 domestic and international members who represent the biotechnology, medical device and pharmaceutical industries; as well as members of the academic, regulatory and scientific research communities. Third party organizations that support these groups include: Contract Research Organizations, consultants, hardware and software vendors and placement firms and represent an important portion of the Society s membership. SCDM Core Values Knowledge and Experience of our Members The intellectual capital and collective experience of our members are our greatest assets. SCDM relies on and embraces the participation and contributions of our members and volunteers. Scholarship SCDM encourages and promotes rigor and discipline in the research of topics affecting our industry. Our positions, publications and programs are the result of scholarly investigation. Quality and Continuous Improvement SCDM is committed to the development and enhancement of products, services and relationships of the highest quality. Open Communication SCDM encourages open communication and information sharing. We provide our members with insight to the organization s initiatives and activities. Integrity SCDM exemplifies and expects honesty and integrity. SCDM Certification Philosophy The Society for Clinical Data Management established the certification program for clinical data managers to institute a standard of knowledge, education and experience by which clinical data managers would be professionally recognized by the medicinal, biological development and medical device therapies community. Through a rigorous application and examination process certified clinical data management professionals are able to demonstrate a high level of competence and expertise in their field. The SCDM certification program was designed to meet the following goals: Establish and promote professional practice standards throughout clinical data management Identify qualified professionals within the profession Ensure recognition of expertise Enhance the credibility and image of the profession
About the CCDM Exam The CCDM exam, revised and released in September 2008, contains 130 multiple choice questions. Candidates are allotted 3.5 hours for this exam. Application Process Certification application is available online at https://www.scdm.org/certification/ application/default.aspx. An application is also included in the back of this handbook and marked as Appendix 1. Please send all certification applications to your relevant office: American Office Global Headquarters India Office Society for Clinical Data Management, Inc 300 Avenue de Tervueren B-1150 Brussels, Belgium Tel: +32-2-740.22.37 Fax: +32-2-743.15.50 info@scdm.org Society for Clinical Data Management, Inc 1444 I Street, NW, Suite 700 Washington DC, 20005, USA Tel: +1-202-712.9023 Fax: +1-202- 216.9646 info-am@scdm.org Society for Clinical Data Management, Inc 410, Madhava, Behind Family Court Bandra Kurla Complex, Bandra (East) 400051 Mumbai, India Tel: +91 22 61432600 Fax: +91 22 67101187 Info-in@scdm.org What are the Costs? The cost to sit for the SCDM CCDM exam is $250 (US). The Society for Clinical Data Management will accept check, money order or credit card. **Note: if we are unable to process your application, a portion of the application fee less administrative costs, will be returned to you. However, once your application is accepted, the fee is nonrefundable. Certification Application Status Once your application has been processed, approximately 14 days after it is submitted, you will receive a letter of acceptance, denial, or a request for further information. The letter of acceptance will include an eligibility ID required to schedule your exam. You will have 90 days from the date of your acceptance letter to take your exam. The 90 days is referred to as your eligibility period. We recommend that you schedule your exam immediately upon receipt of your acceptance letter. Rejection of Certification Application Applicants must meet at least one of the eligibility requirements listed on the Eligibility Requirements Document marked as Appendix 2. If an applicant does not meet the requirements, they will be entitled to a full refund. Testing Agency The certification exam will be offered at Prometric test centers, the professional testing agency secured by contract to assist SCDM in the administration, scoring and analysis of the 2
certification examination throughout North America and internationally. Once your application has been accepted, you will schedule the date and time of your exam directly through Prometric. What to provide when scheduling your exam Candidates must provide Prometric with eligibility ID number, exam name and preferred exam date when making an appointment. Prometric will only schedule appointments for paid exam. When candidates make appointments, Prometric will provide instructions about ID requirements and test center locations. Scheduling Your Exam To schedule your exam online, access the Prometric Web site www.prometric.com. In the United States and Canada, Prometric will use best efforts to provide Candidates with a test seat within fifty (50) miles and thirty (30) days of his/her requested date and location. Outside the United States and Canada, Prometric will make reasonable efforts to provide each Candidate a test seat within one hundred (100) miles and thirty (30) days of his/her requested date and location. Thirty (30) days is defined as fifteen (15) calendar days before Candidate s requested appointment and fifteen (15) calendar days after Candidate s requested appointment. Extensions Applicants may request an extension of their eligibility period due to serious medical reasons, personal tragedy, or unforeseen events. The following rules apply: Must request extension two weeks prior to scheduled examination (if possible) Must be seriously ill (or member of immediate family seriously ill) Documentation may be requested Applicants must contact the SCDM office directly for all extensions by phone, mail or e-mail. No Show, Late Arrival and Rescheduling The Exam Cancellation/Change Deadline for any exam that has been scheduled is as follows: United States and Canada two business days notice prior to exam before noon EST Outside the US and Canada five business days notice prior to exam before noon Regional Registration Center (RRC) time Cancellations/changes must be made and confirmed direct contact with RRC, CSCC or test site personnel, or through the Prometric Registration Web site. Leaving a message on a recorder or a voice mail (except through the IVR system) is not sufficient to confirm cancellation/change. Once the Candidate has registered and is scheduled for an appointment time at a Prometric test site, the Candidate cannot transfer his or her appointment to another Prometric test site that is not served by the same Regional Center. 3
Candidates will be charged the entire certification exam fee in the event that they negligently no show for the certification exam. SCDM realizes that there are extreme cases, i.e., sudden illness, death of an immediate family member or an accident on the way to the exam that prohibits you to sit for the exam. Candidate will be expected to present a physician s note, death certificate/obituary, police/accident report, or other valid documentation to reschedule. Candidate will be assessed a fee to reschedule the exam. This fee covers SCDM costs for adjusting eligibility and registration records. What to expect when you get to the Test Site Identification and Check-in Prometric check-in procedures will include Candidate identification verification either through verification of one photo ID containing a signature or verification of one signature ID. Prometric will require all Candidates to sign a Prometric logbook. Signature in the logbook will be checked against the Candidate ID signature. Candidates will be required to sign the logbook upon completion of the Exam as well as at check-in. If Candidate has no valid ID, Candidate must, prior to an appointment, arrange with SCDM for approval of an alternate form of ID. SCDM will in-turn contact Prometric at a telephone number designated by Prometric before Candidate's scheduled appointment date specifying exactly what ID is acceptable. Candidates who do not produce a valid ID at the scheduled appointment will not be allowed to take the Exam. Candidates will be charged a cancellation fee equal to the Per-Exam Delivery Charge for the appointment time scheduled, and Candidate will not receive a refund of the Candidate testing fee. If Candidate arrives more than fifteen (15) minutes late for a scheduled appointment, the test center staff may choose not to seat the Candidate if doing so disrupts the test center's other scheduled appointments. If the test center staff does not seat the Candidate, due to late arrival, there will be no refund of the Candidate testing fee. Taking the test There is ample time (3.5 hours) allocated to take the test. During the exam, you are permitted to take unscheduled breaks, however please note, the clock will not stop. You should plan to bring a snack or beverage with you since these provisions may not be available at all test centers. Equipment provided at the test center Minimum standard test center equipment is a Pentium based computer with at least a 100 Mhz CPU, 32 MB RAM, 17" SVGA Color Monitor, 8Mb Video RAM, Creative Sound Blaster Sound Card, and headphones (for listening to passages during an assessment). Workstation Operating System is Windows 98. The certification exam is compatible with these operating parameters. ADA Compliance The physical construction of test centers located in the United States will at all times conform in 4
all material respects to the standards established by the Americans with Disabilities Act of 1990 (ADA). The test centers located outside the United States will make reasonable efforts to accommodate Candidates in a manner substantially similar to the standards of ADA, but Prometric will not guarantee complete conformance with ADA. In the event special accommodations are needed such as a reader, amanuensis, or signer, the candidate must contact SCDM for assistance; Prometric testing centers are not required to have these services available. Refunds Once you schedule your test date it will be important that you take the test on your scheduled date. A fee will be assessed if you miss your scheduled test date without following the rescheduling procedures listed on the Prometric website. Preparing for the Exam SCDM offers a webinar series at least four times per year on topics related to the exam as well as for professional development. SCDM also offers face-to-face workshops twice per year in collaboration with Duke University s Clinical Research Institute. The Annual Conference sessions are also a significant source of information and are archived on our website. Finally, Good Clinical Data Management Practices (GCDMP) is a foundational resource that will also help with exam preparation and is available in print form and as podcasts. The SCDM Education Web Portal (http://portal.scdm.org) is an excellent source for additional resources to help candidates prepare to sit for the exam. This portal includes a self-assessment tool to help identify areas needing further study and direct users to helpful resources. These resources will include online short courses, reference materials and the DataMatters listserv to help answer questions and coach candidates as they study for the exam. After the Exam Notification of Results Upon completion of the exam your results will appear on your screen. You will receive a print out of your results at the test site. If you pass the exam After completing the examination, candidates will receive, via mail, a CCDM certificate, CCDM pin and test results. Those who successfully complete the examination are asked to fill 5
out a survey which will be incorporated into SCDM publications. Candidates who pass may use the appropriate credential immediately. If you do not pass the exam The applicant may retake the exam within one (1) calendar year of the formal notification letter date of your original exam results. After that, a full application must be submitted and the full fee structure applies. The fee to retake the CCDM exam is $225 (US). A retake exam application is available online and can be found at the back of this handbook, it is marked Appendix 3. 6
CCDM Renewal SCDM Certified Clinical Data Management professionals (CCDMs) are required to renew their certification every three years from the time of their original certification. By renewing, CCDMs demonstrate their willingness to continue to advance within the field and commitment to continued growth in both knowledge and competency in clinical data management. The CCDM renewal application must be submitted along with: Renewal or exam fee CEU submission form, Appendix 4 (required for non-scdm CEU courses only) CEU certificates from all educational events (Non-SCDM) The renewal application can be found at the back of this handbook; it is marked Appendix 5. To renew certification, candidates must acquire a minimum of 1.8 CEUs within 3 years. This time frame begins from the date of certification until the date the CCDM eligibility expires. Obtaining CEUs through Educational Training and Conferences SCDM requires that at least 60% of CEUs come from clinical data management (CDM) specific training. SCDM allows up to 40% of CEUs to come from non-cdm specific training such as Society volunteer activities. SCDM recommends that CEU applicants consider the CCDM Core Competencies when choosing any non-cdm specific training. For further explanation, view the CEU percentage breakdown chart (Appendix 6) SCDM will accept CEU certificates for training completed within organizations that offer IACET CEUs. CEU certificates must be provided for each training course completed. Certificates for CEUs from public/nonprofit organizations (SoCRA, DIA, ACRP, Universities)as well as private organizations (Barnett, EDC and Beyond, etc), will be considered equally; however, internal company training is not applicable. CEU certificates for training completed by organizations that do NOT offer IACET CEUs are accepted only when the applicant has submitted the Non-IACET CEU Affidavit Form to the SCDM Administrative Office and said provider is approved by SCDM. The affidavit can be found in the back of this handbook, marked Appendix 7. 7
* CEU Certificates must include the following: Workshop title Date of offering Name of sponsoring organization Specific number of CEUs issued Signature and date of representative from sponsoring organization 8
Appendix 1 Application for Certified Clinical Data Manager (CCDM ) Examination Please type or print all information within this application, indicate responses where required, sign in the appropriate spaces, and return with a check, money order or credit card information for a nonrefundable application fee of $250 (US) and required enclosures to: American Office Global Headquarters India Office Society for Clinical Data Management, Inc 300 Avenue de Tervueren B-1150 Brussels, Belgium Tel: +32-2-740.22.37 Fax: +32-2-743.15.50 info@scdm.org Society for Clinical Data Management, Inc 1444 I Street, NW, Suite 700 Washington DC, 20005, USA Tel: +1-202-712.9023 Fax: +1-202- 216.9646 info-am@scdm.org Society for Clinical Data Management, Inc 410, Madhava, Behind Family Court Bandra Kurla Complex, Bandra (East) 400051 Mumbai, India Tel: +91 22 61432600 Fax: +91 22 67101187 Info-in@scdm.org In the event that your application is rejected, a portion of your application fee, less administrative and handling costs, may be returned to you. Once the application is accepted, no refund will be granted. Please allow14 days for processing of your application. Upon confirmation of your qualifications, you will receive a letter with an identification number to present to Prometric to schedule your examination. 9
*Required field Last Name* First Name* MI* (Enter name exactly as it appears on your passport or photo identification ~ PLEASE PRINT OR TYPE) Current Employer: Title: Department: *Mailing Address: *City State/Province Zip/Postal Code *Daytime Phone: Evening Phone: *Fax: *E-mail: 10
Appendix 1 Section 1 Have you taken this examination previously? No Yes Date EDUCATION (Please indicate highest degree earned) No Degree BS or BA MS or MA PhD Other NOTE: Enter degrees obtained in the table below. If you satisfy the maximum experience requirements of four years or more, then the following degree information is not required. EDUCATION RECORD Educational Institution Attended Year Degree Obtained Degree Obtained 11
Appendix 1 Section 2 WORK EXPERIENCE (List any relevant positions held and indicate the CDM tasks performed during the time you held those positions. Reference the CDM task list on the following page.) NOTE: You must include an updated copy of your resume or CV. Company Name, Address and Phone Supervisor s or Manager s Name Employment Dates Position Title CDM Tasks (Please use the list on the following page as a guide) FTE/PTE 12
Appendix 1 * Please use the appropriate task letter from the CDM Task List when completing the Work Experience section on page 3. Task CDM TASK LIST Letter A B C D E F G H I J K L M N O P Q R S T U V W X Y Z AA BB CC Protocol review CRF Design Data Management Plan development (includes database specifications, electronic edit checks, data review guidelines, annotated CRF) CRF tracking and inventory CRF data verification (data entry discrepancy resolution) CRF data validation (i.e. scrubbing, cleaning, query generation, applying data handling conventions) Manual CRF review Query resolution (i.e. correspondence with investigator sites to obtain resolution to queries) Query tracking Communication of data trends Database updates Safety review Coding adverse events/signs and symptoms Coding medications SAE reconciliation Processing local laboratory data (collected via CRF) Processing (loading/merging) central laboratory data Maintenance of laboratory normal range information Application of randomization schemes to study databases (i.e. breaking the blind) Database lock procedures Database quality control audits Review of final data listings Review of final data tables or graphs Review of final reports Archiving database and associated documentation CRO management Relational Databases The data management software and data structures which allows the user to store and manipulate data from specific studies including capabilities to import and export specific data from compatible software. Time Management Utilizing techniques to effectively organize and use own time for the accomplishment of project and organizational goals. Project Management Utilizing techniques to effectively organize and manage multidisciplinary resources to deliver projects or programs to customer expectations. 13
Appendix 1 Section 3 ELIGIBILITY CERTIFICATION I have read and understand the information in attached Eligibility Requirements Document. I hereby represent and warrant that I am eligible to apply to take the CCDM Examination because I meet the eligibility requirements in the following manner (indicate eligibility category and complete blank if applicable.) Bachelor s degree or higher plus two or more years full time experience as a CDM Associate s degree (two years) plus three or more years full time experience as a CDM No degree plus four or more years full time experience as a CDM AUTHORIZATION I hereby authorize the Society for Clinical Data Management (SCDM) to make whatever inquiries it deems necessary and appropriate to confirm the accuracy of the contents of my application. I agree to provide any additional authorizations necessary to that process. I hereby authorize SCDM to use the information contained in my application and examination for purposes of statistical analysis, provided that my personal identifying information has first been deleted. APPLICATION INFORMATION I hereby certify that I have reviewed the information contained in this application and that it is complete and truthful. I understand that my presenting false or incomplete information may be cause for loss of eligibility to take the CCDM examination, for denial of my application for certification or for revocation of any certification granted. EXAMINATION I understand that I may be disqualified from taking or completing the CCDM examination or from receiving examination scores if SCDM determines through proctor observation or otherwise that I engaged in inappropriate behavior during the examination. CLINICAL DATA MANAGEMENT ACTIVITY I hereby represent and warrant that I have at all times acted in compliance with the SCDM Code of Ethics and with those laws and regulations applicable to clinical research, including without limitation, the Declaration of Helsinki and applicable U.S. Food and Drug Administration regulations. I understand that conduct at all times in violation of the spirit of the Code of Ethics or applicable laws makes me ineligible to take the certification examination and can be cause for permanent revocation of my certification status. TERMS AND CONDITIONS OF USE OF THE CCDM CERTIFICATION MARK I hereby agree that, should I become a certified professional, I will abide and be governed by the Terms and Conditions of Use of CCDM Certification Mark, a copy of which has been provided to me. Candidate s Signature: Date: 14
Appendix 1 Section 4 CONFIDENTIALITY AGREEMENT In consideration of your participation in the examination process that forms the basis for SCDM s Certified Clinical Data Manager Certification Program ( the Program ), and to set forth a clear understanding of your obligations relating to the Program, you agree as follows: (1) To preserve the integrity of the Program, you will maintain test questions and your knowledge of the contents of and the subject matter addressed in those questions ( the Test Questions ), in confidence and will refrain from disclosing or using them. (2) Your obligation of nondisclosure does not apply to substantive information that was in your possession prior to this agreement or which became public through no fault or omission on your part, provided, however, that you may not disclose to others whether such substantive information is or is not a part of the Program s certification examination. Your obligation of nondisclosure shall also not apply if you are required to disclose Test Questions in connection with a legal or administrative proceeding, provided, however, that you agree to give the SCDM Certification Committee chair prompt written notice of such a request. (3) All intellectual property rights, including without limitation all copyright, are the sole and exclusive property of SCDM. SCDM shall have the right to obtain and hold in its name rights of copyright, copyright registrations and any similar protection. (4) All nondisclosure obligations imposed by this agreement shall terminate ten (10) years from the date of this agreement. (5) You represent and warrant that you are empowered to enter into this agreement and to grant and assign the rights granted and assigned herein to SCDM. You further represent and warrant that you have not previously granted or assigned, in whole or in part, to any other person or entity, including without limitation your employer, any of the rights granted or assigned herein to SCDM. (6) This agreement shall be construed in accordance with the laws of the State of Wisconsin. AGREED: Signature Print Name Date 15
Appendix 1 Section 5 PAYMENT INFORMATION Please include a check, money order or credit card number and expiration date for a NON-REFUNDABLE* application fee $250. This fee must be paid in U.S. Dollars. *In the event that your application is rejected, a portion of your application fee, less administrative and handling costs, may be returned to you. Once the application is accepted, no refund will be granted. Method of Payment: VISA MasterCard AMEX Check Credit Card Number: Expiration Date: / Name on Card: Signature: NOTE: Please contact the SCDM Administrative Office at info@scdm.org if you would like to submit your exam fee via a wire transfer. 16
Appendix 2 Eligibility Requirements for the Certified Clinical Data Manager Examination You do not need to be a member of the Society for Clinical Data Management (SCDM) to apply for or take the examination to become a Certified Clinical Data Manager (CCDM ). You do not need to be currently employed as a Clinical Data Manager (CDM) in order to apply for or take the examination. You do not have to have a college degree to be eligible to take the examination; however, you must meet one of the following criteria: Bachelor s degree or higher plus two or more years full time CDM experience Associate s degree (two years) plus three or more years full time CDM experience No degree plus four or more years full time CDM experience Part-time work experience will be translated into full time work experience Anyone who has had his/her CDM certification currently suspended is not eligible to take the certification examination until his or her suspension is completed. Anyone whose name is on the FDA debarment list or has had his or her certification permanently revoked is not eligible to take the certification examination. 17
Appendix 3 Application for Certified Clinical Data Manager (CCDM ) Examination Retake You may retake the exam within one (1) calendar year of the formal notification letter date of your original exam results. After that, a full application must be submitted and the full fee structure applies. The fee to retake CCDM exam is $225. Candidate Name: Candidate ID: Candidate Home Address:* Candidate Daytime Phone:* Candidate E-mail: *Mandatory item your application will not be processed without this information. Retake Fee: $225 Method of payment: (Make checks payable to: Society for Clinical Data Management) Visa MasterCard American Express Check enclosed Note: Credit Card information is kept secure. Credit Card Number: Expiration Date: (month/year): / Name on Card (please print): Signature: Date: NOTE: Please contact the SCDM Administrative Office at info@scdm.org if you would like to submit the fee via a wire transfer. 18
Appendix 4 Submission Form Use this form for professional development activities: IACET CEUs Webinars, conferences, forums, tutorials Listing of other SCDM involvement (committees, published articles, presentations) Non-SCDM educational activity Title of Activity Completion Date Sponsoring Organization Number of Contact Hours Evidence of Attendance Office Use Only Name: SCDM ID# Date: E-mail: Contact Hours are actual time spent in the educational activity minus breaks Evidence of Attendance can be a copy of a certificate or letter of completion/attendance. 1 contact hour =.1 CEU 19
Appendix 5 Certification Renewal Application Please type or print all information below, indicate responses where required, sign in the appropriate space and return with the required enclosures to: American Office Global Headquarters India Office Society for Clinical Data Management, Inc 300 Avenue de Tervueren B-1150 Brussels, Belgium Tel: +32-2-740.22.37 Fax: +32-2-743.15.50 info@scdm.org Society for Clinical Data Management, Inc 1444 I Street, NW, Suite 700 Washington DC, 20005, USA Tel: +1-202-712.9023 Fax: +1-202- 216.9646 info-am@scdm.org Society for Clinical Data Management, Inc 410, Madhava, Behind Family Court Bandra Kurla Complex, Bandra (East) 400051 Mumbai, India Tel: +91 22 61432600 Fax: +91 22 67101187 Info-in@scdm.org Section 1 First Name* Last Name* MI* (*Enter name as it should appear on the certificate) Company Name Title Department Mailing Address City State/Province Zip/Postal Code Country Work Phone Fax E-mail 20
Please include a current copy of your resume or CV, which should include updated education and work experience since your last application. CCDM s certified after 2004, will need to accumulate 1.8 CEUs for CCDM renewal or you may choose to take the current CCDM examination. I have acquired CEU's Please submit the attached form listing accumulated CEUs. If non-iacet CEUs were obtained, please complete the Non-IACET Affidavit Form I will take the CCDM exam. Appendix 5 Section 2 Fee: Renewal Application Fee: $95 CCDM Exam $250 Method of payment: Visa Mastercard American Express Credit Card Number: Expiration Date: Name on Card: Signature: Check Enclosed * The renewal fee is NON-REFUNDABLE. In the event that your application is rejected, a portion of your application fee, less administrative and handling costs, may be returned to you. Once the application is accepted, however, no refund will be granted. 21
Appendix 5 SECTION 3 AUTHORIZATION I hereby authorize the Society for Clinical Data Management (SCDM) to make whatever inquiries it deems necessary and appropriate to confirm the accuracy of the contents of my application. I agree to provide any additional authorizations necessary to that process. I hereby authorize SCDM to use the information contained in my application and/or examination for purposes of statistical analysis, provided that my personal identifying information has first been deleted. APPLICATION INFORMATION I hereby certify that I have reviewed the information contained in this application and that it is complete and truthful. I understand that my presenting false or incomplete information may be cause for loss of eligibility to take the CCDM examination, for denial of my application for re-certification or for revocation of any certification granted. EXAMINATION I understand that I may be disqualified from taking or completing the CCDM examination or from receiving examination scores if SCDM determines through proctor observation or otherwise that I engaged in inappropriate behavior during the examination. CLINICAL DATA MANAGEMENT ACTIVITY I hereby represent and warrant that I have at all times acted in compliance with the SCDM Code of Ethics and with those laws and regulations applicable to clinical research, including without limitation, the Declaration of Helsinki and applicable U.S. Food and Drug Administration regulations. I 22
understand that conduct at all times in violation of the spirit of the Code of Ethics or applicable laws makes me ineligible to take the certification examination and can be cause for permanent revocation of my certification status. TERMS AND CONDITIONS OF USE OF THE CCDM CERTIFICATION MARK I hereby agree that, should I become a re-certified professional, I will abide and be governed by the Terms and Conditions of Use of CCDM Certification Mark, a copy of which has been provided to me. Candidate s Signature Date Appendix 6 Competency Domains Addressed in CCDM Exam Section 1 Project Management Scope, Definition and Management Project Management Process Design, Management and Documentation Project Management Project Communications EDC Overall Clinical Trials Process, Roles & Responsibilities Protocol Review Data Management Plans Clinical Database Design/Relational Databases CRF Design Section 2 Processing Lab Data Maintenance of Lab Normal Range Information CRF Tracking Communication of Data Trends Query Resolution Query Tracking CRF Data Entry Process Discrepancy Resolution CRF Data Validation (e.g. data review, cleaning, query generation, applying data handling conventions) Database Updates Section 3 SAE Reconciliation/Safety Review 23
Coding (AEs; Signs and Symptoms) Coding Medication Database Quality Control Audits Database Lock Procedures Application of Randomization Schemes (Breaking the Blind) Appendix 7 CEU & Participation Credit Percentage Chart 24
Appendix 8 Non-IACET CEU Affidavit Form For non-scdm educational offerings, applicant must sign affidavit below and include all course materials, brochure and/or advertisement of course as well as a corroborating reference signature. Affidavit Requirement I verify under penalty of revocation, that I successfully completed the course titled offered by (Institution) on the dates of Duration of course* Participant Signature Date Reference Signature Date * excludes break and meal times Attachments required for approval 25
acceptable) Society for Clinical Data Management 1. Printed description and details provided by the educator 2. Speaker information (Bio/Curriculum Vitae) 3. Attendance Verification (A Certificate of Completion is the only verification 26